Multi-event October 2017 FDA Recall Zoloft by Pfizer Inc.
This Multi-event Class II drug recall was voluntarily initiated by Pfizer Inc. on October 20, 2017 for the product Zoloft. The FDA reported the reason for recall as superpotent. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0151-2018
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
10-20-2017
01-10-2018
1972 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-02-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
Batch or Lot Expiration Information
Lot# Lot: S84026
Affected Packages Involved in this Recall
Recall Number: D-0150-2018
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
10-20-2017
01-10-2018
183437 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-02-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977
Batch or Lot Expiration Information
Lot# Lots: a) R83962, R93347, R93348, R93349, R93350, R93351, R93352, Exp. 2021 OCT 31; S57831, S57832, S57834, Exp. 2021 NOV 30 b) R93356, R93357, R93358, R97310, Exp. 2021 OCT 31.
